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A science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. We have 3 global businesses that research, develop and manufacture innovative pharmaceutical medicines, vaccines and consumer healthcare products. We aim to bring differentiated, high-quality and needed healthcare products to as many people as possible, with our 3 global businesses, scientific and technical know-how and talented people.
Provides effective and efficient quality assurance systems support tthe LOC Quality Manager, including supporting the implementation and maintenance of the QMS and as directed by the LOC Quality Manager performs the day tday work tensure that the quality systems required by the LOC element of the Supply Chain and Marketing Company LOC are performed in a lean and efficient way and meet the compliance standards of the QMS and the local Regulator.
KEY ACCOUNTABILITIES / RESPONSIBILITIES :
- Quality Strategy
- Maintain a high level of QMS knowledge and awareness of changes within the commercial environment tseek opportunities and manage potential business adversity.
- Gain an understanding of the Supply Chain and Commercial LOC Business and Quality Plans at a high as they potentially link tday tday and quality improvement activities.
- Quality Systems
- Supporting the LOC Quality Manager tensure a robust, sustainable and effective QMS (Quality Management System) through monitoring and reviewing the compliance status within the
- LOC element of the Supply Chain and (GlaxoSmithKline East Africa) Marketing Company.
- Support the implementation and maintenance of effective Quality Assurance systems tensure that local operations are in full compliance with GSK standards and policies, Guide for
- Commercial Companies ,GMP, GDP and regulatory requirements by supporting the LOC Quality Manager as directed to:
- Ensure that all SOPs are in place, updated & training has been conducted across the business. Ensure a monitoring system in place for tracking training compliance and process for escalation of persistent non-compliance. Processes in place for delivering routine training for updates tSOPs, GQPs, and GQMPs as relevant.
- Promote QMS management principles and seek continuous improvement of the processes
- Review, conduct impact assessments and implement any updates tQMS policies
- Manage QMS Management Review meetings according tlocal SOPs
- Identify, Implement and Manage QA Objectives & KPIs
- Establish and manage Annual Quality Plans
- Support the LOC Quality Manager tensure that all internal procedures and systems in use in the LOC are compliant tGSK QMS, Guide for Commercial Companies and local regulatory requirements, including (but not limited to)
- LOC Quality Council – support the LOC Quality Manager re organizing Council meeting with regular meetings. This support should ensure that the LOC Quality Council format, frequency and reporting are standardised tglobal requirements. In addition support should be provided re Quality metrics and reporting format/ system in place.
- Change Control – perform day tday work tsupport the local change control process with the aim of ensuring all planned major changes (including as appropriate new pack introduction, product discontinuation, major pack changes, re-packing activities) are effectively and compliantly managed. Processes in place troutinely review progress of changes and close out when completed.
- Risk Management – perform activities tsupport the risk management process tensure effective management, timely reporting, review and escalation of quality risks.
- Corrective and Preventative Actions (CAPA) – Implement global or local process teffectively manage corrective and preventative action plans. Develop local processes tconduct root cause analysis tinvestigate deviations and develop CAPA’s. Local process in place ttrack and review CAPA plans on routine basis. Demonstrate that LOC effectively identifies where CAPA plans required and that they are effectively implemented, monitored and closed out.
- Auditing – perform day tday work tsupport the local process that is in place for Level 1 (self-inspection) and Level 2 monitoring auditing. Work with the LOC Quality Manager tensure the Level 1 and Level 2 auditing process includes clear accountability for sign off of audit reports and resultant CAPA/ Risk management. Level 1 and Level 2 audit universe is defined and agreed with Regional Quality and annual audit schedules in place. There is a process in place tensure all new and existing suppliers/ 3rd party contractors/ service providers that have a direct impact on product quality are identified and audited by either LOC QA Team or the appropriate Central Team (e.g. ESA). e.g. distribution sites, repacking contractors, warehouses, freight management, samples supply, off-site archive sites, artwork printers, printed packaging component suppliers. LOC element of the Supply Chain and the Quality elements of the
- Marketing Company are audit ready for any relevant Level 3 or 4 audits.
- Complaints – perform day tday work tsupport an effective complaints management process ensuring the assessment of potential issues are determine as quickly as possible and linked to the adverse event reporting process and local product incident process if/as appropriate.report and follow up on product complaints with manufacturing sites, customers and commercial teams.
- Incident management – Support the LOC Quality Manager tensure that an effective local product incident process is in place tescalate and manage any product quality related issues and in the training of all relevant staff in local incident management process and global PIRC process. Assist the LOC Quality Manager in any investigations triggered by local incidents and in conducting LOC Incident Committees.
- Product supply – performs day today work tsupport systems that have an impact on the quality of imported, products in line with the QMS and local Regulatory requirements responsible for the review and at the direction of the LOC Quality Manager the approval of TTS (Technical Terms of Supply) and liaison with manufacturing sites tensure compliance tlocal registered technical details. Liaison with External Supply Quality for products that are manufactured by contractors tensure compliance tlocal registered technical details. Ensure timely local Quality release of imported finished goods deliveries and resolve Quality-related issues arising from these deliveries. Support the LOC Quality Manager with communication tthe GMS supplying sites, R&D and Regional Quality as it relates tapproval of repacking activities and resolving Quality issues with the product supplied
- Artwork management – perform day tday work in line with the roles and responsibilities for quality as defined in the local artwork procedures.
- Local Repacking – perform day tday work tsupport repacking requests ensuring regulatory and QA compliance, timely QA batch release of repacked orders before distribution and/or re-export. Ensure as appropriate documentation of batch records and retention of samples.
- Acts in the role of the Quality Systems Manager in the absence of the LOC Quality Manager.
- Maintains all quality documentation such as product specifications and Standard Operating Procedures in accordance with GSK policies.
- Ensures all product specifications and related documents (e.g. CoAs, TTs) are maintained compliant tcurrent registered details.
- Maintains and updates the QA Standard Operating Procedures
- Successful completion of relevant tertiary qualifications – Science Degree
- Minimum of 2 years experience within the Pharmaceutical / Consumer Healthcare industries, preferably in the capacity of a senior quality specialist or a manager
- Understanding of and experience in quality assurance systems particularly in the areas of batch release, product incidents, artwork control and performing audits
- Knowledge of regulatory requirements pertaining tGMP/GDP
- Knowledge of effective quality documentation systems
Essential Skills and Abilities:
- Ability to deliver clear communications and foster excellent working relationships with peers and management
- Analytical mind, good attention tdetail and problem solving skills within a structured process
- Good team player – works well in cross-functional teams
- Ability tmulti-task and work under pressure
- Concise in the description of the different QA situations. Able tstick tthe standard and not be pressurized.
- Works with a spirit of continuous improvement and innovation, creatively open tnew ideas and methods
- Flexible thinking – able tchallenge and see views from different perspectives
- Ability tself-motivate and be resilient and focused under pressure
Strong general computer literacy with Intermediate skills in Microsoft Word, Excel, Power Point and Outlook